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Next Generation Trial Design for HIV Prevention Research

As clinical trials in HIV prevention grow in complexity, advocacy for future trial design is more important than ever.

Since AVAC’s founding, we’ve understood—and advocated—that the people most impacted by HIV must be involved in the design and implementation of clinical trials. Even as prevention options grow, trials to test new HIV prevention methods remain crucial as high rates of new infections persist in communities all over the world. As proven products roll out, including oral PrEP now and other options in the near future, innovative trial design is a focus and challenge for the field. Advocates and communities must play a central role in shaping future trial design. Their input is essential for both community acceptance of clinical trials and for trial results that advance the field. As trial designs grow more complex, this need is greater than ever.

AVAC’s Evolving Designs for HIV Prevention Trials is a two-page introduction to the issue. It features a table describing key trial designs under discussion, links to background material, and a table on three trials testing next-generation PrEP options, including: monthly oral PrEP with islatravir from Merck; a new form of daily oral PrEP with F/TAF from Gilead; and six-monthly injectable PrEP with lenacapavir from Gilead.

The Trial Design Academy

Launched in September of 2019, AVAC’s Trial Design Academy convenes HIV prevention advocates from across the globe to confront the technical challenges, engage with researchers, statisticians, product developers and regulators, and help shape the decisions to move the research agenda forward. Resources generated from the academy are featured below.

Resources

Context and Advocacy

Ethical Guidance